Resected stage III/IV solid tumor or to stage IV solid tumors Cancer
Conditions
Interventions
A vaccine is made from the patient's own tumor tissue (collected during standard of care surgery) and blood. Patients will be seen for a total of four months to receive the initial vaccine and then th
Sponsors
Perseus PCI (USA)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Stage III/IV (resected) solid tumor malignancy 2. Stage IV solid tumor malignancy with accessible tumor 3. Approximately 1 mg (1 cm3) of accessible and dispensable tumor that will not interfere with pathologic staging 4. ECOG 0-1 performance 5. Not involved in other clinical trials 6. Capable of giving informed consent 7. Age 18 to 99
Exclusion criteria
Exclusion criteria: 1. ECOG >2 2. Insufficient tumor available to produce vaccine 3. Immune deficiency disease or HIV, active HBV, or active HCV 4. Steroids or other immunosuppressants
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety of of the autologous TLPLDC vaccine at baseline, month 1, 2, 3 and at each standard of care visit to the treating medical oncologist. Safety data will be collected on local and systemic toxicities and graded and reported per the Common Terminology Criteria for Adverse Events (CTCAE) v4.03. | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy of the autologous TLPLDC vaccine at baseline, month 1, 2, 3 and at each standard of care visit to the treating medical oncologist. Disease-free status/tumor response will be monitored per standard of care as dictated by the patients’ treating medical oncologist. This information will be obtained from the patient and/or the referring medical oncologist. Follow-up scans will be assessed for tumor response per RECIST v1.1. | — |
Countries
Cayman Islands
Outcome results
None listed